Fauci: Let's face it -- J&J has always been a two-shot vaccine

Let’s face it — it might have been good to know this up front. Anthony Fauci told Martha Raddatz on ABC’s This Week that the data from Johnson & Johnson on its booster shot demonstrated that “this should have been a two-dose vaccine to begin with.” If that’s the case, then why didn’t the FDA and CDC ask J&J to start testing that regimen right from the beginning?

Were they also too invested in a one-and-done option to question the efficacy results, especially as compared to the mRNA vaccines from Pfizer and Moderna? Because this looks like a rather embarrassing whiff eight months later:

RADDATZ: Dr. Fauci, the FDA advisory panel unanimously recommended booster doses for the J&J vaccine, but the advice is for all people over 18 to get the shot, even after just two months. We know this vaccine was not as effective as others. So should those 15 million people who got the vaccine be concerned, given these recommendations?

FAUCI: No, not at all, Martha. I think that they should feel good about it, because what the advisers to the FDA felt is that, given the data that they saw, very likely, this should have been a two-dose vaccine to begin with.

So, the idea of making a recommendation that people who originally received J&J should receive a second dose 18 or older with none of the restrictions about whether or not you’re at a high risk or not at a high risk, is that everyone who received that first dose of J&J who are 18 and older should receive it. So I think that’s a very good thing and I think it’s very favorable for those who have received the J&J vaccine. I don’t see that as a problem at all.

To be clear, as a J&J recipient, I have always assumed that this would become a two-dose regimen. Most vaccines require boosters anyway, and some require a second shot to fully prepare the body’s immune system. (In fact, I have been convinced of that long enough that I got a second shot six months after my first without waiting for the FDA and CDC to get around to acknowledging that fact.) This kind of question should have been under testing all along, not months down the road.

Now that they have that data, other studies show that a mix-and-match approach might work better for J&J recipients. Fauci reminds Raddatz, however, that this data comes from laboratory analysis, not clinical data based on real-world outcomes. The clinical data shows that the J&J vaccine holds up well, and that the boosters are highly effective, even if the lab analysis doesn’t duplicate it:

RADDATZ: But, Dr. Fauci, the panel was also looking at new data that suggests J&J recipients may be better off getting a booster shot from the more effective Pfizer or Moderna vaccines, is that a better solution?

FAUCI: That is true, the data you referred to, that if you boost people who have originally received J&J with either Moderna or Pfizer, the level of antibodies that you induce in them is much higher than if you boost them with the original J&J.

However, you are talking about laboratory data, which very often are reflective of what you would see clinically. But the data of boosting the J&J first dose with the J&J second dose is based on clinical data. So what’s going to happen is that the FDA is going to look at all those data, look at the comparison and make a determination of what they will authorize.

This has been a problem with reporting on studies ever since the vaccines first got put into circulation. Laboratory analysis is an important part of the process, but real-world data is much more valuable, especially when it comes to immune responses. The lab analyses tend to focus on antibody presence, but that’s only one aspect of immune system response. The T- and B-cell responses are just as important if not more so, as antibodies routinely decrease after acute exposure — but those cells give the body its ability to produce more on demand. We’d expect antibody production to decrease after a few months, but that doesn’t make people especially susceptible to the virus.

If that were the case, we’d be seeing massive numbers of serious breakthrough cases and deaths among J&J recipients — and we’re not seeing that at all. That’s especially true given that J&J vaccinations largely are front-ended, after the FDA and CDC fumbled the messaging on J&J in mid-spring. Not only aren’t we seeing massive breakthrough cases with J&J, we’re not seeing them much at all relative to overall cases:

Would approving a second J&J shot earlier have improved matters? It doesn’t look like it. If there were large differences in breakthrough cases between the two vaccines, we’d have known about it by now. However, the clinical data on a second shot (and third for the two mRNA vaccines) should have come more quickly, and the FDA and CDC shouldn’t have been in such a rush to embrace J&J as a one-and-done option.